We are partnering with a global Life Sciences organisation undergoing a number of critical digital and compliance initiatives and are seeking an experienced Validation Manager to lead validation activities across regulated clinical and quality systems.
This is an excellent opportunity for a hands‑on CSV professional who combines strong validation expertise with leadership capabilities and experience operating within highly regulated GxP environments.
Key Responsibilities
- Lead validation activities for regulated GxP systems throughout the SDLC.
- Author and review validation deliverables including URS, risk assessments, test scripts, test execution evidence, validation reports and traceability documentation.
- Collaborate with business, quality, IT and vendor stakeholders to ensure compliant system implementation and operation.
- Provide guidance on Computer Systems Validation (CSV), data integrity and regulatory compliance requirements.
- Support validation activities across clinical, quality and enterprise platforms.
5+ years' experience in Computer Systems Validation within Life Sciences
Strong validation experience across clinical and quality systems, including:
- Clinical Systems (CTMS, EDC, IRT advantageous)
Experience validating or implementing Learning Management Systems (LMS), ideally: